What’s in the Fish Feed: Proposed FDA Rule Set to Strengthen Animal Feed Safety in the U.S. and Overseas

Posted By on Dec 4, 2013 | 1 comment

By Kevin Long

The U.S. Food & Drug Agency (FDA) is set to implement new feed safety regulations arising under the Food Safety Modernization Act (FSMA), signed into law by President Obama in January 2011.  The FDA’s recently proposed rules are published in the Federal Register and titled, “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals; Proposed Rule.”[1]  The new FSMA feed laws work together with prior food safety legislation, namely the Federal Food, Drug, and Cosmetic Act, and impact feeds used in aquaculture production.

The U.S. Federal Government has regulated animal feed for over 100 years, with roots in the 1906 Pure Food & Drug Act.  With multiple federal agencies involved in the area, including the FDA, the Environmental Protection Agency, the Department of Agriculture, Customs and Boarder Patrol, and likely others, animal feed policy and laws in the U.S. are complex.  Further, there are also separate regulatory regimes for every state and territory, yet most do incorporate federal law.  Another wrinkle in the U.S. animal feed regulatory framework is that feed provided to animals destined for human consumption is considered “food” in much of the law, with a common-sense policy goal of protecting animal health to protect human health.

The Food, Drug, and Cosmetic Act (FDCA) of 1938, along with its subsequent amendments and additions, comprise the nation’s predominant food and feed law.  The FDCA provides feed labeling rules, special rules for medicated feeds, rules for feeds containing other additives, import notice requirements, rules on how the government deems a product “adulterated,” and the procedure for ordering detentions and investigations.[2]  While the FDCA does provide Good Manufacturing Practices (GMP) rules for feeds containing drugs, it lacks general GMP guidance pertaining to feed.

The Food Safety Modernization Act (FSMA), in conformity with its name, aims to “create new current good manufacturing practice (CGMP) regulations that specifically address the manufacturing, processing, packing, and holding of animal food.”[3] The FSMA also includes preventive control measures for feed facilities already required to register under the FDCA, potentially including certain importers of feed[4].  “These preventive controls would include requirements for covered facilities to maintain a food safety plan, perform a hazard analysis, and institute preventive controls for the mitigation of those hazards.”[5]  Additionally, facilities must maintain documented records of the controls, including the actions taken and the outcomes.[6]

The proposed Current Good Manufacturing Practices (CGMPs) provide guidance to the industry on setting procedures in all areas involved.  From facilities to layout and design to proper maintenance to personnel hygiene, the areas targeted by the new rules reflect the developments in science as well as the growing awareness of the significant risks associated with contaminated feed.  Further, the new regulations would require Hazard Analysis and Critical Control Point (HACCP) systems specifically for fish and fishery products.[7]  HACCPs inform and provide guidelines to feed producers and other industry players in minimizing risks associated with improper storage or processing of feed or feed ingredients.  While the HACCP method has been in place in the U.S. for years, it is critical that the systems address the varying threats across the different industry sectors.

In a global seafood and aquaculture industry, where food and feed products originate from all over the world, it is ever more critical that national and international policymakers reassess feed laws in an attempt to strike a balance between the practical needs of the industry and the need to protect the health of consumers.  As the FDA’s proposed feed safety rules are set to take effect at the end of the month (60 days after the publication in the Federal Register), it will be important to monitor their implementation and the response of the aquaculture and related feed industry.


[Web Link to Proposed Rules. Federal Register Volume 78, Number 209 (Tuesday, October 29, 2013): http://www.gpo.gov/fdsys/pkg/FR-2013-10-29/html/2013-25126.htm]



[1] Federal Register Volume 78, Number 209 (Tuesday, October 29, 2013).

[2] Most feed related regulations fall under the Code of Federal Regulations (CFR), Title 21, Subchapter E on Animal Drugs, Feeds, and Related Products.

[3] Federal Register Volume 78, Number 209 (Tuesday, October 29, 2013) at Page 64738.

[4] See separate proposed rule published in the Federal Register on July 29, 2013 (78 FR 45730). This proposed foreign supplier verification program is closely interconnected to the rules on preventive controls for animal food.

[5] Federal Register Volume 78, Number 209 (Tuesday, October 29, 2013) at Page 64738.

[6] Id.

[7] Id. at Page 64818.

See also: FDA, “Fish and Fishery Products Hazards and Controls Guidance,

Fourth Edition” (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Seafood/ucm2018426.htm)